Study Demonstrates Accuracy in Blood Glucose Test Strip

A study published recently in the Journal of Diabetes Science and Technology (JDST) evaluated the accuracy of commercial blood glucose test strip platforms for patients with diabetes.¹ In the report, the authors highlighted the clinical accuracy of OneTouch Select Plus blood glucose test strips.²

The study used approximately 21,000 data points from more than 200 different OneTouch Select Plus test strip batches, routinely and regularly sampling across 3 years of production to assess product accuracy, according to the manufacturer's press release.² Investigators evaluated the test strips with a minimum of 100 subjects with diabetes, and then compared the readings with capillary blood samples collected at the same time.¹

The study found that 97.6% of the batches met the accuracy criterion of 97.1-98.1% by year. The product also demonstrated clinical accuracy across all 7 glucose ranges. Under combined conditions of hematocrit and glucose extremes, 97.7% of values were clinically accurate.²

"In this study, results are based on more than 21,000 blood glucose meter readings gathered in a clinical setting and paired against corresponding reference instrument readings — all using OneTouch Select Plus test strips – over a period of years,” said Guido Freckman, MD, medical director of the Insitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, in a prepared statement.² “This sort of continuous, systematic testing methodology enhances the picture of performance given by other accuracy studies, including those I have authored."

This is not the first time that researchers have tested OneTouch products. In both an April 2017 study and a March 2018 JDST study, experts tested the OneTouch Verio Flex platforms and found consistent high accuracy.²

According to the authors of the most recent study, due to publication of sometimes-conflicting data presented within ad hoc blood glucose monitoring clinical accuracy evaluations, they recommend that manufacturers adopt similarly robust and systematic surveillance programs to better safeguard patients.¹

References

• Setford, S., Phillips, S., Grady, M. Evidence From a Long-Term, Systematic Post-Market Surveillance Program: Clinical Performance of a Hematocrit-Insensitive Blood Glucose Test Strip. Journal of Diabetes Science and Technology. https://doi.org/10.1177/1932296819826968. Published February 7, 2019. Accessed February 12, 2019.
• Lifescan, Inc. OneTouch Blood Glucose Monitoring System Accuracy Proven in New Long-Term Study [news release]. Chesterbrook, Pennsylvania; February 8, 2019: Lifescan. https://www.prnewswire.com/news-releases/onetouch-blood-glucose-monitoring-system-accuracy-proven-in-new-long-term-study-300791765.html. Accessed February 12, 2019.